1. Field of the Invention
The present invention is directed to a method of treating human immuno-deficiency virus (HIV-1) infections and to the discovery that a mammalian liver extract is efficacious in treating such infections. The present invention is also directed to a method of treating HIV-1 infections with this same mammalian liver extract. The present invention is further directed to a method of preparing a colloidal dispersion for use with this same mammalian liver extract. The present invention is also directed to a method of using a rectal suppository colloidal dispersion delivery system to treat HIV-1 infections.
2. Brief Description of Prior Art
Acquired immune deficiency syndrome (AIDS) and AIDS-related complex (ARC) are caused by human immuno-deficiency virus (HIV-1), a retrovirus. The HIV-1 virus infects immune, neural, and other cells of its host. Eventually most people infected with HIV-1 become abnormally susceptible to a variety of serious opportunistic diseases as a result of the immune deficiency caused by the virus.
The current anti-HIV-1 drugs are either not effective or cause undesirable side effects. These drugs include AZT, 2', 3'-dideoxy cytidine (ddCyd), interferon (IFN), mismatched double stranded RNA (dsRNA) and amphotericin B. In particular, AZT, which has shown some promise in the treatment of AIDS, causes very serious side effects, such as bone marrow suppression, in a high proportion of patients. Also, the beneficial effects of AZT have been reported to abate in 12-18 months, and patients get new infections or develop toxic side effects. (Chase, "Doctors and Patients Hope AZT Will Help Stave Off AIDS," Wall Street Journal, Apr. 28, 1988, p. 14, col. 1.)
One commercially available mammalian liver abstract useful for purposes of the present invention is sold under the trademark KUTAPRESSIN by Kremers-Urban Co., of Milwaukee, Wis. According to product literature, this extract exerts its action only with respect to tissues that have been injured, and particularly when inflammation and edema are present.
U.S. Pat. No. 5,055,296, filed by certain inventors common to the present application further discloses use of a particular heat stable, acetone-insoluble, water-soluble mammalian liver extract, designated as "KU 10,001" that was shown to be effective in the treatment of mammals infected with a non-dermatological virus and, in particular, chronic fatigue syndrome. The disclosure of this patent as to such extracts are incorporated herein by reference. This patent also discloses preliminary results of this extract as a protector of MT-2 cells using an in vitro test culture, when exposed to HIV-1.
U.S. Pat. No. 5,284,664, filed by certain inventors common to the present application, disclose a heat stable, acetone-insoluble, water-soluble mammalian liver extract, that is said to be effective in the treatment of symptoms of Alzheimer's Disease. The liver extract was also partially sequenced, and that sequence listing is incorporated herein by reference.
U.S. Pat. No. 5,316,775, filed by certain inventors common to the present application, discloses the same mammalian liver extract and demonstrates it to be effective in the treatment of Hepatitis B infections.
U.S. Pat. No. 5,334,395, filed by certain inventors common to the present application, discloses use of the same mammalian liver extract and demonstrates it to be effective in the treatment of Epstein-Barr viral infections.
U.S. Pat. No. 4,254,103, discloses a method of extracting Hepatoprotector Factor (HF) from bovine liver to be used in the treatment of cirrhosis of the liver and viral hepatitis.
U.S. Pat. No. 5,492,937, discloses a composition which is a liquid at or below room temperature, and forms a highly viscous gel at body temperature. This composition is comprised of a cellulose ether, a surfactant, and other optional additives. It may be used for oral or local administration of a pharmaceutical to the skin, mucous membrane, eye, or body cavity.
Against this background, the inventors have endeavored to discover a method to treat HIV-1 infections, using a heat stable, acetone-insoluble, water-soluble mammalian liver extract.